Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-28 @ 12:05 PM
Study NCT ID:
NCT04445935
Status:
UNKNOWN
Last Update Posted:
2020-06-24
First Post:
2020-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C074619', 'term': 'bivalirudin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study will be blinded to the above mentioned group. The PI is not involved in active treatment. Patients are sedated and ventilated when treatment starts and finally the outcome assessors will not be knowing the patients treatment.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P/F ratio', 'timeFrame': 'three days of intervention', 'description': 'the P/F ratio is a surrogate parameter for oxygenation in ARDS.'}], 'secondaryOutcomes': [{'measure': 'Kidney function', 'timeFrame': 'three days of intervention', 'description': 'The kidney function frequently is deteriorated in COVID-19 patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'ARDS', 'Anticoagulation'], 'conditions': ['Anticoagulation in COVID-19 ARDS']}, 'referencesModule': {'references': [{'pmid': '35244208', 'type': 'DERIVED', 'citation': 'Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.'}, {'pmid': '32895056', 'type': 'DERIVED', 'citation': 'Kharma N, Roehrig S, Shible AA, Elshafei MS, Osman D, Elsaid IM, Mustafa SF, Aldabi A, Smain OAM, Lance MD. Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 7;21(1):769. doi: 10.1186/s13063-020-04689-1.'}]}, 'descriptionModule': {'briefSummary': 'Patients with COVID-19 associated ARDS and mechanical ventilation have a high mortality. Part of the disease is an activation of the coagulation system which seems to contribute to clotformation in the pulmonary bloodstream. Recently we implemented an algorithm applying higher doses of heparins (LMWH). However, this approach could not inhibit clotformation enough. Bivalirudin could prevent clotformation better and support dissolving existing clots.\n\nTherefore, we want to compare 50 patients with the standard treatment with 50 patients under bivalirudin treatment which we normally apply in patients with a HIT-syndrome.\n\nOur primary outcome measure is oxygenation reflected as P/F ratio.', 'detailedDescription': 'The pandemic of COVID-19, a newly upcoming viral disease caused by SARS-CoV-2, puts the whole worlds health system under pressure.\n\nPatients suffering from this disease mainly develop respiratory symptoms, which can lead to severe acute respiratory distress syndrome (ARDS) necessitating ICU admission in 10-20% of the cases admitted to hospital. In addition to these symptoms, patients show lymphopenia, cardiac symptoms and altered coagulation profiles. Although those patients are treated in the ICU the mortality there is more than 20% due to multiorgan failure.\n\nOne of the recent insights in this disease is its effect on the coagulation system. Meanwhile we know that the coagulation system gets activated. Furthermore, it seems that clot formation takes place in the pulmonary micro-vasculature which could contribute to the widely observed gas-exchange impairment. Therefore, many centers apply empiric anticoagulation for their COVID-patients. At the moment, we at HMC, also apply an empirical anticoagulation protocol as our standard approach. However, this is a symptomatic treatment without good proof.\n\nBivalirudin is a well-known agent which is used in HMC for cases in which anticoagulation is needed, but a contraindication for heparin exists (i.e. HIT syndrome). This drug has an interesting pharmacologic profile. It acts independent of antithrombin (AT), the physiological compound which enhances heparin effects under normal circumstances. This lack of dependence on AT, makes Bivalirudin an attractive choice in light of the contradictory reports on the levels of AT during COVID infection. If AT levels are decreased during the infection, heparin (as well as LMWH) cannot work efficiently, which would render our treatment less effective. Luckily, bivalirudin acts without the support of AT, so we could bypass this problem. In addition, bivalirudin has some fibrinolytic activities. It inhibits clot-bound thrombin which as a result destabilizes the clot rendering it more susceptible to thrombolysis. This property partially supports the dissolving of clots and could support re-opening the pulmonary microcirculation.\n\nObjectives:\n\nTo prove the positive effect of anticoagulation with bivalirudin intravenously on gas-exchange in patients with COVID-19 and respiratory failure on invasive mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (≥ 18 years of age)\n* Positive COVID-test\n* Under mechanical ventilation\n* D-Dimers\\>1.2 mg/L\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy to the drug (bivalirudin)\n* Inherited coagulation abnormalities\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT04445935', 'briefTitle': 'Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'Anticoagulation in Patients Suffering From COVID-19 Disease-The Anti-Co Trial', 'orgStudyIdInfo': {'id': 'MRC-05-082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'In this arm the patients will be treated according to our standard anticoagulation protocol.\n\nThe patients will not be treated with Bivalirudin (the investigational drug).', 'interventionNames': ['Drug: Standard treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Bivalirudin arm', 'description': 'The patients will be anticoagulated according to the institutional HIT-protocol which uses Bivalirudin as anticoagulant.', 'interventionNames': ['Drug: Bivalirudin Injection']}], 'interventions': [{'name': 'Bivalirudin Injection', 'type': 'DRUG', 'otherNames': ['anticoagulation'], 'description': 'The patients will receive iv Bivalirudin according to the institutional HIT protocol.', 'armGroupLabels': ['Bivalirudin arm']}, {'name': 'Standard treatment', 'type': 'DRUG', 'description': 'This group will receive standard anticoagulation with LMWH/UFH', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Doha', 'status': 'RECRUITING', 'country': 'Qatar', 'contacts': [{'name': 'Nadir Kharma, MD', 'role': 'CONTACT', 'email': 'nkharma@hamad.qa', 'phone': '00974', 'phoneExt': '55118621'}], 'facility': 'Hamad Medical Corporation', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'centralContacts': [{'name': 'Marcus Lance, MD, PhD', 'role': 'CONTACT', 'email': 'mlance@hamad.qa', 'phone': '00974', 'phoneExt': '33530292'}, {'name': 'Stefan Roehrig, MD, MBA', 'role': 'CONTACT', 'email': 'srohrig@hamad.qa', 'phone': '00974', 'phoneExt': '66030924'}], 'overallOfficials': [{'name': 'Marcus Lance, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'this will depend on IRB advice'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. Marcus Lance', 'investigatorFullName': 'Dr. Marcus Daniel Lance', 'investigatorAffiliation': 'Hamad Medical Corporation'}}}}